U.S. patent number 4,168,000 [Application Number 05/855,847] was granted by the patent office on 1979-09-18 for suture package.
This patent grant is currently assigned to American Cyanamid Company. Invention is credited to David C. MacRitchie.
United States Patent |
4,168,000 |
MacRitchie |
September 18, 1979 |
Suture package
Abstract
A catgut suture package is disclosed which upon opening exposes
the looped end of a catgut suture. The suture loop is directly
dispensed from the package leaving the label intact within the
envelope.
Inventors: |
MacRitchie; David C. (New
Milford, CT) |
Assignee: |
American Cyanamid Company
(Stamford, CT)
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Family
ID: |
27112785 |
Appl.
No.: |
05/855,847 |
Filed: |
November 30, 1977 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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734800 |
Oct 22, 1976 |
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Current U.S.
Class: |
206/63.3;
206/210 |
Current CPC
Class: |
A61B
17/06133 (20130101) |
Current International
Class: |
A61B
17/06 (20060101); A61L 017/02 () |
Field of
Search: |
;206/210,63.3,363 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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469054 |
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Dec 1928 |
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DE2 |
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1409244 |
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Jul 1965 |
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FR |
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Primary Examiner: Price; William
Assistant Examiner: Moy; Joseph Man-Fu
Attorney, Agent or Firm: Costello, Jr.; Charles F.
Parent Case Text
RELATED TO OTHER APPLICATIONS
This application is a continuation-in-part of Ser. No. 734,800,
filed Oct. 22, 1976, now abandoned.
Claims
I claim:
1. A direct dispensing suture package comprising:
a transparent envelope being heat sealed to form an enclosure, said
enclosure comprising a label chamber and a bell-shaped chamber,
each chamber including two side portions and one end portion, said
side portions of said label chamber being substantially parallel
and then converging toward each other to meet the side wall
portions of said bell-shaped chamber, the width of said label
chamber being greater than said bell-shaped chamber;
at least one tearing notch adjacent one of said side portions of
said bell-shaped chamber, said tearing notch being located to
permit tearing action across said bell-shaped chamber;
a textured surface for gripping by hand adjacent said side porions
of said bell-shaped chamber, said surface of such a size as to
prevent hand pressure on said bell-shaped chamber;
a label folded into at least about two equal parts contained in
said label chamber, the width of said folded label being larger
than said bell-shaped chamber;
a needled suture strand held in said label, with the end of said
strand looped into said bell-shaped chamber, and with the needle
laid onto said label for preventing said suture strand from being
damaged by said needle, whereby when said bell-shaped chamber is
opened from said notch and the end of said strand is pulled by hand
or by a needle holder, said strand is directly dispensed from said
package by unwinding within said envelope, leaving said label in
said label chamber.
2. The package described in claim 1 wherein said label is folded
into about four equal parts.
3. The package described in claim 1 wherein said label is folded
horizontally from the bottom.
4. The package described in claim 1 wherein said label is folded
vertically from one side.
5. The package described in claim 1 wherein said label contains
suture identifying information.
6. The package described in claim 1 wherein said envelope contains
a conditioning liquid.
7. The package described in claim 6 wherein said strand is
catgut.
8. The package described in claim 1 wherein said strand is
nylon.
9. The package described in claim 1 wherein said strand is
dacron.
10. The package described in claim 1 wherein said strand is
polyethylene.
11. The package described in claim 1 wherein said strand is
polypropylene.
Description
BACKGROUND OF THE INVENTION
This invention relates to a suture package which permits direct
dispensing of a sterile surgical suture with or without a needle
attached. More specifically, to a suture package having a bell
shaped configuration that can be torn from a tear notch across the
lower portion of the bell shape to expose a looped end of the
sterile surgical suture. A suture is a strand of material suitable
for suturing, with or without an attached needle, used for ligating
or other surgical procedures.
The packaging of many commercial products is essential to the
proper and use of the product and thus forms an integral part of
the overall product design. The significance of packaging is most
evident in the packaging of surgical sutures. It is essential that
the package protect the product and maintain sterility throughout
its period of potential use. Sutures may be stored in hospitals for
several years, although the usual storage time is much shorter. It
is essential that the package provide rapid and positive means of
identification and release the product undamaged ready for use by
the surgeon. There are many sizes of sutures, and many materials of
construction such as catgut or polyglycolic acid for absorbables,
silk, cotton, nylon, dacron, polyethylene, polypropylene, stainless
steel, insulated stainless steel and other materials for use as
non-absorbables. There are several different needle types in common
use including pointed straight, pointed curved, three cornered
straight, three cornered curved, curved both regular and reverse
cutting, and needles with side cutting edges of various types. The
variations and combinations of each of these to meet the preference
of many surgeons for different operative procedures means that the
suture manufacturer needs to supply different suture combinations
running into the thousands. The importance of positive
identification and efficient, economical packaging can thus be
readily appreciated.
It is also important to provide convenience to the use and limit
the risk of accidently enclosing foreign items in the patient by
limiting the number of extraneous packaging materials associated
with use of the product in the operating theater. A count is often
kept to ensure that each item is accounted for and removed from the
operating field. Considering the ramifications of enclosing such
material in the patient accidently during surgical procedures, it
is obviously essential to minimize this hazard.
It is also important that the surgical package properly present the
suture suitably oriented within the package so that the user can
rapidly and reliably have access to the suture end, either needled
or non-needled, in the proper position for dispensing from the
package.
It is important also, to provide a standard packaging format for
all multiple suture materials to limit confusion on the part of the
user during surgical procedures. Over the years various package
styles have evolved that have detracted from user convenience and
operating room efficiency. For purposes of storage in the hospital
as well as economy of manufacture, it is highly desirable that as
many suture combinations as feasible be packaged in a minimum
number of different package styles and shapes and storage units. It
is quite common to package 3 dozen identical sutures in a box. It
is convenient to have most of the boxes about the same size and
shape, so that the hospital may store them most conveniently. It is
also convenient from the manufacturers stand point to be able to
reduce his inventory of box sizes and to be able to use the same
components for the maximum number of suture combinations in the
product line.
It is essential that a package containing a needled surgical suture
protect the suture from contact with the sharp point or cutting
edge of the needle which could partially cut or fray the
suture.
These requirements are so rigorous and of such importance that many
different package designs have been tried. Applicant is not aware
of any prior art reference which, in his respective judgment as one
skilled in the suture packaging art, would anticipate or render
obvious the suture package of the instant invention; however, for
the purpose of fully developing the background of the invention and
establishing the state of the requisite art, the following
references are set forth: U.S. Pat. Nos. 3,939,969; 3,357,550;
3,221,873; 3,202,273; and 2,949,181. These patents are incorporated
herein by reference. Generally, these patents disclose a surgical
suture packaged in an outer plastic or foil strippable envelope.
Contained in the strippable envelope is an inner or pouch which is
sterile. The suture strand has been formed into various retainers,
labels, or reels, within the inner envelope.
The suture is normally prepared for the surgeon by stripping the
outer envelope and transferring the inner envelope by sterile
forceps, or by projecting it across a sterile barrier, into the
sterile areas of the operating room. The inner envelope is opened
at the time of use.
The inner envelope and suture retaining label of the present
invention for a needled or non-needled suture have advantages over
these prior art patents. After tearing the inner envelope of the
present invention, the suture retaining label is used for direct
dispensing of the suture without extracting the label from the
inner envelope. Access to the suture is provided by a loop at the
suture and which is pulled after tearing the inner envelope. The
suture unwinds from its array within the package upon pulling the
loop.
Because the inner envelope, the torn portion of the inner envelope,
and the suture retaining label remain together after opening, the
proliferation of packaging materials within the immediate area of
the operation or other surgical procedure is reduced. In most
operations and surgical procedures, the materials used for the
operation or surgical procedure are counted subsequent to the
operation or surgical procedure. The label, the inner envelope and
the torn portion of the inner envelope of the present invention
provide a readily identifiable and countable package.
Further, the size of the needle and the type of suture strand can
be printed on the suture retaining label. This provides ready
identification in a surgical procedure where more than one size and
type of suture is used. Also, because the inner envelope is clear,
the size and type of suture and needle can be confirmed visually
before the suture is dispensed.
Perhaps of most importance and the greatest advantage to the
package of the invention is the bell shaped configuration of the
top portion of the inner envelope. The bell shaped seal allows more
surface area for grasping by the hand. When the inner envelope
contains a liquid e.g., a conditioning liquid or softening
solution, the bell shaped configuration eliminates or minimizes the
squirting of the liquid or solution by hand pressure on the
envelope. The bell shaped configuration also gives a "bottle
effect" to the package. The wider seal gives more rigidity and
support to the top of the package even after opening. This tends to
keep the opening closed. Also, because there is a narrower opening,
the flow of the liquid is restricted. Also, the narrower opening
tends to retain the liquid within the larger end of the package
after it is opened.
The Bell shaped configuration is unusual in the heat sealing art
generally and in suture packaging specifically. In the heat sealing
art, a contoured shape can be more difficult to fabricate because
of closer tolerances in the tool design of the sealer, and in
sealing pressure applied.
The usual configuration in suture packaging is rectangular with the
remaining side being a chevron or "cathedral roof" configuration.
See, e.g., U.S. Pat. Nos. 3,357,550; 3,256,981 and 2,949,181 which
are incorporated herein by references.
Perhaps of equal importance to the bell shaped configuration is the
direct dispensing of the suture strand from the package of this
invention.
In the prior art, the suture strand has been contained in or on
various retainers, labels, or reels. The suture is dispensed by
opening the package, e.g. by tearing or peeling, pulling out the
wrapped suture, and then unwinding or separating the suture from
its wrapper.
The package of this invention is direct dispensing. Upon opening
the package, the suture is directly removed from the package
without having to unwind or separate the suture from its retainer
label. This has the advantage of saving time, which in a surgical
procedure can be of extreme importance. Another advantage of the
direct dispensing package of this invention is that the suture is
directly dispensed from the end. The suture is thus readily
available for immediate use, either by hand or by use of a needle
holder. Still another advantage is that the suture retainer label
is retained in the package after direct dispensing of the suture.
This has the advantage of reducing the amount of loose packaging
materials in the surgical area. Still another advantage is that,
because an accounting is usually made after a surgical procedure,
the inner envelope, the torn portion of the inner envelope, and the
retainer label can be counted as one piece after direct dispensing
of the surgical suture.
Still another advantage of the package of this invention is the
textured surface of the sealed area. This allows for a secure grip,
for example, by the thumb and index finger. Also, because of the
textured surface, the amount of hand pressure which would have to
be applied to the sealed area during tearing may be reduced.
SUMMARY OF THE INVENTION
A direct dispensing suture package has been invented. By direct
dispensing is meant that only the suture is removed from the sealed
envelope, after the envelope is opened.
This direct dispensing suture package comprises a transparent
envelope which is heat sealed. On three sides of the envelope, the
heat seal is adjacent the edge. On the remaining side, the heat
seal is a bell shaped configuration. In the preferred embodiment,
the package perimeter is rectangular.
Adjacent the lower portion of the bell shaped configuration, and on
the edge of the package is at least one notch. The lower portion of
the bell shaped configuration is the widest part of the bell shape.
In the preferred embodiment, two notches are adjacent the lower
portion on opposite edges of the package.
A textured surface for gripping by hand is adjacent the bell shaped
configuration. The textured surface allows for a secure grip by the
thumb and index finger of the user. The textured surface is of such
a size as to prevent hand pressure on the bell shaped configuration
by the user.
A label is contained in the envelope and is larger than the bell
shaped configuration. Thus when the suture is directly dispensed
from the envelope, the label is retained in the package. In the
preferred embodiment, the label is folded into about four equal
parts. The geometry of the folds is not critical as long as a
suture strand is held in the label and the suture is directly
dispensed after the package is opened. In another embodiment, the
label is folded into at least about two equal parts horizontally
from the bottom. In yet another embodiment, the label is folded
into at least about two equal parts vertically from one side.
In another preferred embodiment, the label contains identifying
information on the suture and/or the needle. Because the envelope
is transparent, the identifying information can be contained on
both sides of the label.
A suture strand is held in the label described above. In the
preferred embodiment, the end of the suture strand looped into the
bell shaped configuration is needled.
In another preferred embodiment, the envelope contains a
conditioning liquid. In the most preferred embodiment, the envelope
contains a conditioning liquid wherein the suture strand is catgut
and the end of the suture strand is needled.
In other embodiments, the suture strand held in the label described
above is either nylon, dacron, polyethylene or polypropylene.
The configuration of the suture strand in the label is not critical
to the practice of this invention except that the configuration
must allow for direct dispensing of the suture when the envelope is
opened. In this regard, a figure eight and a serpentine
configuration have been found to be effective. These configurations
are therefore preferred.
The end of the suture strand is looped into the bell shaped
configuration.
The end of the suture strand is available for visual identification
without opening the package. The end of the suture strand, because
it is looped into the bell shaped configuration, prevents the
suture strand in the label from being damaged. This is especially
important when the end of the suture strand is needled. The bell
shaped configuration is opened from the notch to the opposite lower
portion of the bell shape. The end of the suture strand is then
pulled by hand or by a needle holder for direct dispensing from the
package. The suture strand unwinds within the envelope. The label
is left with the package and the bell shape configuration is left
on the envelope.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of the envelope describing the bell shaped
seal, the notched edges and the textured surface at the smaller end
of the envelope.
FIG. 2 is a front view of the envelope illustrating the opening of
the envelope by hand-tearing across the smaller end. The wide heat
seal area tends to prevent hand pressure on the fluid and to
eliminate squirting.
FIG. 3 is a front view of the opened envelope illustrating the ease
of grasping the loop of catgut suture situated in the smaller end
of the enclosure. The torn portion is not detached from the
envelope.
FIG. 4 is a front view of the inner envelope illustrating the
direct dispensing of catgut suture from the envelope. The label
remains within the envelope.
DESCRIPTION OF THE PREFERRED EMBODIMENT
This invention relates to catgut sutures which are needled and
non-needled. The envelope contains a conditioning liquid which is
required for the preservation of catgut sutures. Conventional
conditioning liquids include ethyl alcohol or a mixture of ethyl
alcohol, isopropyl alcohol, and water. Conditioning liquids can
also contain a germicidal agent, and/or a rust inhibitor to prevent
rusting of needles which may be attached to the sutures.
Although the bell shaped configuration of the package of this
invention is particularly suited to envelopes containing a suture
in a conditioning liquid, it is to be understood that other suture
materials such as nylon, dacron, polyethylene and polypropylene
could be directly dispensed from the package without the
conditioning liquid. The invention is more fully described in the
figures.
Referring to FIG. 1, on envelope 12 has been contoured heat sealed
16 to form an enclosure 17 which is smaller at one end. The
contoured bell shaped configuration provides an enclosure for a
dispensing loop of the invention. The outer edge of the envelope 12
is notched 13 near the lower portion of the bell shape. The
contoured heat sealed area around the bell shape is textured
10.
As shown in FIG. 3, the envelope 12 is opened by hand-tearing,
beginning at the notch 13, across the smaller enclosure. This
exposes an extended loop 18 of the enclosed catgut suture. The
amount of conditioning liquid 20 in the envelope is such that when
the envelope is opened, the level of the liquid is below the torn
portion 14 of the envelope. The torn portion 14 is not detached
from the envelope 12.
FIGS. 3 and 4 illustrate the direct dispensing of the catgut
suture. In FIG. 3, the catgut suture and 18 is grasped for removal
from the envelope. In FIG. 4 the suture is removed by direct
dispensing of the catgut suture and 18, either by hand as described
or by needle holder. The catgut suture is directly dispensed by
unwinding within the package. The label 19 and the conditioning
liquid 20 are retained within the larger end of the envelope.
The envelope can be designed from two separate, flexible,
transparent sheets. While other flexible transparent materials,
such as polyamid (or nylon), may be used, it is preferred that the
envelope consist of a laminate having an external surface of a
polyester film, such as the polyester of theylene glycol and
terephthalic acid, which is sold under the trademark "Mylar" with
an interior polyethylene or
The envelope can be formed by adhesively uniting the films. It is
preferred, however, to heat seal the films on the inside.
The suture is folded in the label and inserted into the envelope.
In the preferred embodiment, the suture is folded in a figure eight
or serpentine configuration in the label. The label can be made of
any foldable sheet material, such as paper.
The label retains the suture is a configuration for direct
dispensing within the larger end of the inner envelope. The label
also provides identifying information, e.g. as to the length, size,
and type of the suture and the needle.
The envelope can be sterilized by either radiation or by placing
the envelope in a sterilizing chamber containing sterilizing gas,
such as ethylene oxide.
The description of this invention is for preferred embodiments
only. Any modifications which are within the scope of the claims
and which suggest themselves to those skilled in the art are within
the scope of this invention.
* * * * *